Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period thatthe Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES☒NO☐ Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large acceleratedfiler,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Table of Contents PagePART IFinancial Information4Item 1.Financial Statements4Condensed Balance Sheets as of March 31, 2026 (Unaudited) and December 31, 20254Condensed Statements of Operations and Comprehensive Loss for the three months ended March 31, 2026and 2025 (Unaudited)5Condensed Statements of Convertible Preferred Stock and Stockholders’ Equity for the three months endedMarch 31, 2026 and 2025 (Unaudited)6Condensed Statements of Cash Flows for the three months ended March 31, 2026 and 2025 (Unaudited)7Notes to Financial Statements (Unaudited)8Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations21Item 3.Quantitative and Qualitative Disclosures About Market Risk37Item 4.Controls and Procedures37 PART IIOther Information38Item 1.Legal Proceedings38Item 1A.Risk Factors38Item 2.Unregistered Sales of Equity Securities and Use of Proceeds38Item 3.Defaults upon Senior Securities38Item 4.Mine Safety Disclosures38Item 5.Other Information38Item 6.Exhibits39Signatures40 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q (this Quarterly Report) contains forward-looking statements about us and our industrythat involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this QuarterlyReport, including statements regarding our future results of operations, financial condition, business strategy and plans andobjectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-lookingstatements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,”“intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would,” or the negative of thesewords or other similar terms or expressions. We have based these forward-looking statements largely on our current expectations and projections about future events andtrends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Theseforward-looking statements are subject to a number of risks, uncertainties, factors and assumptions described under Part II. Item1A. “Risk Factors” and elsewhere in this Quarterly Report, regarding, among other things: •our expected future growth;•the size and growth potential of the markets for our products, and our ability to serve those markets;•our ability to accurately forecast demand for our products;•the rate and degree of market acceptance of our products;•the expected future growth of our sales and marketing organization;•our ability to implement our multi-channel coverage and reimbursement strategy;•the performance of, and our reliance on, third parties in connection with the commercialization of our products,including single source suppliers;•our ability to accurately forecast and manufacture appropriate quantities of our products to meet commercial demand;•regulatory developments in the United States;•our ability to maintain regulatory approval for our products or obtain regulatory approval for new products in theUnited States;•our research and development for existing products and any future products;•the development, regulatory approval and commercialization of competing products;•our ability to retain and hire senior management and key personnel;•our expectations regarding the period during which we qualify as an emerging growth company under the JumpstartOur Business Startups Act (JOBS Act);•our expectations regarding the impact of geopolitical and macroeconomic factors;•our financial performance and capital requirements;•our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well asour ability to operate our business without infringing the intellectual property rights of others;•our expected use of our existing cash, cash equivalents and short-term and long-term investments, including expecteduse of net proceeds from our initial public offering and other financing transactions; and•other risks and uncertainties, including those described under Part II. Item 1A. “Risk Factors” in this Quarter